Myopic AstigmatismTICL-PASNCT04516772

STAAR Visian Toric ICL Post-Approval Study

A study testing Visian TICL in people with Myopic Astigmatism, run by Staar Surgical Company at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objective of this study is to evaluate the long term (i.e. 24 months) clinical performance of the Visian® Toric Implantable Collamer® Lens (ICL). Read more about this study

Who is it for?: Ages 21 to 45 years
Conditions the study is for: Myopic Astigmatism
What is being tested?: Visian TICL
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 125 participants
Where: 8 sitesUnited States
Study dates: 21 Jul 2020to 11 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Moderate to high myopia with astigmatism correctable with available TICL powers.
Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE) for 1 year prior to implantation.
Able and willing to return for scheduled follow-up examinations after surgery.
Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
Other protocol-specified inclusion criteria may apply.

Who cannot join

Insulin-dependent diabetes or diabetic retinopathy.
History of previous ocular surgery.
Cataract of any grade.
Monocular.
Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study.
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Solomon Eye Physicians and Surgeons/Bowie Vision Institute
Bowie, Maryland, 20716
Cleveland Eye Clinic
Brecksville, Ohio, 44141
Key-Whitman Eye Center
Dallas, Texas, 75243
Hoopes Vision/Hoopes, Durrie, Rivera Research
Draper, Utah, 84020
Aloha Laser Vision, LLC
Honolulu, Hawaii, 96814
Price Vision Group,
Indianapolis, Indiana, 46260
Vance Thompson Vision
Omaha, Nebraska, 68137
Vance Thompson Vision
West Fargo, North Dakota, 58078

Other trials in United States

About this study

Official title: Post-Approval Study of the Visian Toric Implantable Collamer Lens

The objective of this study is to evaluate the long term (i.e. 24 months) clinical performance of the Visian® Toric Implantable Collamer® Lens (ICL).

Read the detailed description

This study will be conducted at 6-8 clinical sites in the US, by surgeons qualified by experience and training to implant Visian Toric ICLs.

Conditions: Myopic Astigmatism
Being tested: Visian TICL
Keywords: nearsightedness, phakic IOL, Toric ICL, TICL, TMICL, Visian, astigmatism
Medical subject headings: Astigmatism, Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Visian TICLDevice
Also called Visian Toric ICL, TMICL
The Visian TICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.

Study groups in NCT04516772
Study group	Role	What they receive
Visian TICL	Other	STAAR Visian Toric implantable collamer lens (TICL) for the correction or reduction of myopia with astigmatism. Receives: Device: Visian TICL

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Axis Orientation of the TICL
Rotation of the TICL of less than or equal to five degrees in 90% of treated eyes between 18 and 24 months postoperative
Measured: 18 to 24 months postoperative

Secondary outcomes (38)

Absolute Rotation of the TICL Between Visits (Change From Operative Visit to Day 1)
Absolute Rotation of the TICL in treated eyes between visits (change from Operative visit to Day 1)
Measured: Day 1 (1-2 days postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Day 1 to Week 1)
Absolute rotation of the TICL in treated eyes between visits (Change from Day 1 to Week 1)
Measured: Week 1 (5-9 days postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Week 1 to Month 1)
Absolute rotation of the TICL in treated eyes between visits (Change from Week 1 to Month 1)
Measured: Month 1 (3-5 weeks postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 1 to Month 3)
Absolute rotation of the TICL in treated eyes between visits (Change from Month 1 to Month 3)
Measured: Month 3 (10-14 weeks postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 3 to Month 6)
Absolute rotation of the TICL in treated eyes between visits (Change from Month 3 to Month 6)
Measured: Month 6 (21 - 26 weeks postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 6 to Month 12)
Absolute rotation of the TICL in treated eyes between visits (Change from Month 6 to Month 12)
Measured: Month 12 (11 - 14 months postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 12 to Month 18)
Absolute rotation of the TICL in treated eyes between visits (Change from Month 12 to Month 18)
Measured: Month 18 (17 - 21 months postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 18 to Month 24)
Absolute rotation of the TICL in treated eyes between visits (Change from Month 18 to Month 24)
Measured: Month 24 (23 - 27 months postoperatively)
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Operative Visit)
Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit
Measured: Operative Visit
Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1)
Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit
Measured: Day 1 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Week 1 Visit)
Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit
Measured: Week 1 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 1 Visit)
Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit
Measured: Month 1 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 3 Visit)
Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit
Measured: Month 3 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 6 Visit)
Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit
Measured: Month 6 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 12 Visit)
Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit
Measured: Month 12 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 18 Visit)
Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit
Measured: Month 18 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 24 Visit)
Absolute rotation of the TICL in treated eyes <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit
Measured: Month 24 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Operative Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Operative Visit)
Measured: Operative Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Day 1 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Day 1 Visit)
Measured: Day 1 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Week 1 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Week 1 Visit)
Measured: Week 1 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 1 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 1 Visit)
Measured: Month 1 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 3 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 3 Visit)
Measured: Month 3 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 6 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 6 Visit)
Measured: Month 6 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month12 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 12 Visit)
Measured: Month 12 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 18 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 18 Visit)
Measured: Month 18 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 24 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 24 Visit)
Measured: Month 24 Visit
Manifest Refraction Spherical Equivalent (MRSE) at Month 1
Postoperative manifest refraction spherical equivalent (MRSE) at each visit
Measured: Month 1
Manifest Refraction Spherical Equivalent (MRSE) at Month 3
Postoperative manifest refraction spherical equivalent (MRSE) at each visit
Measured: Month 3
Manifest Refraction Spherical Equivalent (MRSE) at Month 6
Postoperative manifest refraction spherical equivalent (MRSE) at each visit
Measured: Month 6
Manifest Refraction Spherical Equivalent (MRSE) at Month 12
Postoperative manifest refraction spherical equivalent (MRSE) at each visit
Measured: Month 12
Manifest Refraction Spherical Equivalent (MRSE) at Month 18
Postoperative manifest refraction spherical equivalent (MRSE) at each visit
Measured: Month 18
Manifest Refraction Spherical Equivalent (MRSE) at Month 24
Postoperative manifest refraction spherical equivalent (MRSE) at each visit
Measured: Month 24
Manifest Refraction Cylinder at Month 1
Postoperative manifest refraction cylinder at each visit
Measured: Month 1
Manifest Refraction Cylinder at Month 3
Postoperative manifest refraction cylinder at each visit
Measured: Month 3
Manifest Refraction Cylinder at Month 6
Postoperative manifest refraction cylinder at each visit
Measured: Month 6
Manifest Refraction Cylinder at Month 12
Postoperative manifest refraction cylinder at each visit
Measured: Month 12
Manifest Refraction Cylinder at Month 18
Postoperative manifest refraction cylinder at each visit
Measured: Month 18
Manifest Refraction Cylinder at Month 24
Postoperative manifest refraction cylinder at each visit
Measured: Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jul 202011 Dec 2024

First posted18 Aug 2020
Study start21 Jul 2020
Primary completion11 Dec 2024
Study completion11 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Myopic AstigmatismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: All enrolled subjects will undergo phakic eye surgery to have the STAAR Visian Toric Implantable Collamer Lens (TICL) implanted in one or both eligible eyes.
Masking: None (open label)
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04516772
Sponsor's protocol ID: CP18-02
Acronym: TICL-PAS
Status last verified: Mar 2026
First submitted: 10 Aug 2020
Last updated: 13 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myopic Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Approval Study of the Visian Toric Implantable Collamer Lens
ClinicalTrials.gov ID: NCT04516772
Acronym / sponsor ID: TICL-PAS / CP18-02
Conditions: Myopic Astigmatism
Keywords: nearsightedness, phakic IOL, Toric ICL, TICL, TMICL, Visian, astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: Staar Surgical CompanyIndustry (pharma, biotech, devices)
Study start: 21 Jul 2020 (actual)
Primary completion: 11 Dec 2024 (actual)
Study completion: 11 Dec 2024 (actual)
First posted: 18 Aug 2020 (actual)
Results: Posted 13 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to evaluate the long term (i.e. 24 months) clinical performance of the Visian® Toric Implantable Collamer® Lens (ICL).

Detailed description

This study will be conducted at 6-8 clinical sites in the US, by surgeons qualified by experience and training to implant Visian Toric ICLs.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: All enrolled subjects will undergo phakic eye surgery to have the STAAR Visian Toric Implantable Collamer Lens (TICL) implanted in one or both eligible eyes.

Arm	Type	Receives
Visian TICL	Other	Device: Visian TICLSTAAR Visian Toric implantable collamer lens (TICL) for the correction or reduction of myopia with astigmatism.

Who may qualify

Ages: 21 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Moderate to high myopia with astigmatism correctable with available TICL powers.
Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE) for 1 year prior to implantation.
Able and willing to return for scheduled follow-up examinations after surgery.
Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (6 listed)

Insulin-dependent diabetes or diabetic retinopathy.
History of previous ocular surgery.
Cataract of any grade.
Monocular.
Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Visian TICLAlso: Visian Toric ICL, TMICLThe Visian TICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.	Device	Visian TICL

Primary outcome

Change in Axis Orientation of the TICL
Time frame: 18 to 24 months postoperative
Rotation of the TICL of less than or equal to five degrees in 90% of treated eyes between 18 and 24 months postoperative

38 secondary outcomes

Absolute Rotation of the TICL Between Visits (Change From Operative Visit to Day 1)
Time frame: Day 1 (1-2 days postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Day 1 to Week 1)
Time frame: Week 1 (5-9 days postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Week 1 to Month 1)
Time frame: Month 1 (3-5 weeks postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 1 to Month 3)
Time frame: Month 3 (10-14 weeks postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 3 to Month 6)
Time frame: Month 6 (21 - 26 weeks postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 6 to Month 12)
Time frame: Month 12 (11 - 14 months postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 12 to Month 18)
Time frame: Month 18 (17 - 21 months postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 18 to Month 24)
Time frame: Month 24 (23 - 27 months postoperatively)
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Operative Visit)
Time frame: Operative Visit
Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1)
Time frame: Day 1 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Week 1 Visit)
Time frame: Week 1 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 1 Visit)
Time frame: Month 1 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 3 Visit)
Time frame: Month 3 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 6 Visit)
Time frame: Month 6 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 12 Visit)
Time frame: Month 12 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 18 Visit)
Time frame: Month 18 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 24 Visit)
Time frame: Month 24 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Operative Visit)
Time frame: Operative Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Day 1 Visit)
Time frame: Day 1 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Week 1 Visit)
Time frame: Week 1 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 1 Visit)
Time frame: Month 1 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 3 Visit)
Time frame: Month 3 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 6 Visit)
Time frame: Month 6 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month12 Visit)
Time frame: Month 12 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 18 Visit)
Time frame: Month 18 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 24 Visit)
Time frame: Month 24 Visit
Manifest Refraction Spherical Equivalent (MRSE) at Month 1
Time frame: Month 1
Manifest Refraction Spherical Equivalent (MRSE) at Month 3
Time frame: Month 3
Manifest Refraction Spherical Equivalent (MRSE) at Month 6
Time frame: Month 6
Manifest Refraction Spherical Equivalent (MRSE) at Month 12
Time frame: Month 12
Manifest Refraction Spherical Equivalent (MRSE) at Month 18
Time frame: Month 18
Manifest Refraction Spherical Equivalent (MRSE) at Month 24
Time frame: Month 24
Manifest Refraction Cylinder at Month 1
Time frame: Month 1
Manifest Refraction Cylinder at Month 3
Time frame: Month 3
Manifest Refraction Cylinder at Month 6
Time frame: Month 6
Manifest Refraction Cylinder at Month 12
Time frame: Month 12
Manifest Refraction Cylinder at Month 18
Time frame: Month 18
Manifest Refraction Cylinder at Month 24
Time frame: Month 24

Results and safety

Results posted to the registry on 13 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Visian TICL	125	111

Primary outcome: Change in Axis Orientation of the TICL

Time frame: 18 to 24 months postoperative. Count of units. Unit: Eyes

Measure	Primary Eyes n = 108
Less than 5 degrees rotation	104
Missing	4

Population analysed: The number of primary (first implanted) eyes with TICL rotation less than or equal to 5 degrees between 18 and 24 months postoperative.

38 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Eyes	29 of 232 (12.5%)	40 of 232 (17.2%)	0 of 232
Non-Ocular Serious Adverse Events	2 of 125 (1.6%)	0 of 0	0 of 125

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myopic Astigmatism

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joanne Egamino, PhD study director

VP, Clinical Affairs

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Visian TICL in people with Myopic Astigmatism, run by Staar Surgical Company at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Axis Orientation of the TICL (time frame: 18 to 24 months postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04516772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.